Melanoma Clinical Trial

A Study to Evaluate KIN-2787 in Participants With BRAF and/or NRAS Mutation Positive Solid Tumors

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

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Full Description

This is a two-part, open-label, multi-center, dose escalation and dose expansion study in participants with BRAF mutation-positive and/or NRAS mutation-positive tumors designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of KIN-2787, a RAF small molecule kinase inhibitor, to determine a recommended Phase 2 dose (RP2D) of KIN-2787, and to assess the objective response to KIN-2787 therapy alone and in combination with binimetinib, a mitogen-activated protein kinase (MEK) inhibitor.

The dose expansion phase (Part B) will assess the safety and efficacy of KIN-2787 at the recommended dose and schedule in patients with cancers that contain BRAF Class II or III mutations, including lung cancer, melanoma, and other selected solid tumors.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Provide written informed consent prior to initiation of any study-specific procedures.
Metastatic or advanced stage solid tumor
Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA.
Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
ECOG performance status 0-1
Adequate organ function, as measured by laboratory values (criteria listed in protocol).
Able to swallow, retain, and absorb oral medications.

Exclusion Criteria:

Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain criteria)
In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
Active, uncontrolled bacterial, fungal, or viral infection.
Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is excluded
Women who are lactating or breastfeeding, or pregnant.
In Part B Dose Expansion, patients with BRAF Class I mutations are excluded.
Participants with any other active treated malignancy within 3 years prior to enrollment

Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

155

Study ID:

NCT04913285

Recruitment Status:

Recruiting

Sponsor:

Kinnate Biopharma

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There are 20 Locations for this study

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City of Hope
Duarte California, 91010, United States More Info
Providence
Fullerton California, 92835, United States More Info
David Park
Contact
[email protected]
UCSD Moores Cancer Center
La Jolla California, 92093, United States More Info
Julia Appelt, CCRC
Contact
858-822-0201
[email protected]
University of Southern California
Los Angeles California, 90033, United States More Info
Judy Lam-Tran
Contact
323-865-3879
[email protected]
Jacob Thomas
Principal Investigator
UCLA
Los Angeles California, 90095, United States More Info
Jessica Crocker
Contact
[email protected]
Bartosz Chmielowski, MD
Principal Investigator
Stanford Cancer Center
Stanford California, 94305, United States More Info
Debjani Ghoshal
Contact
[email protected]
Chris Chen, MD
Contact
[email protected]
Chris Chen, MD
Principal Investigator
Orlando Health Cancer Insitute
Orlando Florida, 32806, United States More Info
Sajeve Thomas, MD
Contact
[email protected]
Sajeve Thomas, MD
Principal Investigator
Sarah Cannon Research Institute - Lake Nona
Orlando Florida, 32827, United States More Info
Moffitt Cancer Ceter
Tampa Florida, 33612, United States More Info
Cody Likens
Contact
Hao Xie, MD, PhD
Principal Investigator
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Ryan Ramaekers, MD
Principal Investigator
NYU Langone
New York New York, 10016, United States More Info
Judy Kwak
Contact
646-754-4637
[email protected]
Janice Mehnert, MD
Principal Investigator
Thomas Jefferson
Philadelphia Pennsylvania, 19107, United States More Info
Sheri McDougall
Contact
[email protected]
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Anthony Olszanski, MD
Contact
[email protected]
Anthony Olszanski, MD
Principal Investigator
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
Contact
844-482-4812
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Carrie Friedman, RN, BSN, OCN
Contact
703-636-1473
[email protected]
Melanoma Institute Australia
Wollstonecraft New South Wales, 2065, Australia
Linear Clinical Research
Perth Western Australia, 6009, Australia More Info
Michael Millward, Professor
Contact
(08) 6382 5100
[email protected]
Institut Bergonie
Bordeaux , , France More Info
Antonie Italiano
Contact
+33 5 47 30 60 88
[email protected]
Antonie Italiano, MD
Principal Investigator
Centre Leon Berard
Lyon , , France More Info
Philippe Cassier
Contact
+33 4 26 55 68 33
[email protected]
Philippe Cassier, MD
Principal Investigator
APHM-CHU La Timone
Marseille , , France More Info
CHU Nantes-Hotel Dieu
Nantes , , France More Info
Stephanie Bordenave
Contact
+33 2 40 16 59 30
[email protected]
Stephanie Bordenave, MD
Principal Investigator
Gustave Roussy
Villejuif , 94805, France More Info
David Planchard, MD
Contact
+ 33 (0)1 42 11 45 64
[email protected]
David Planchard, MD
Principal Investigator
Netherlands Cancer Institute
Amsterdam , , Netherlands More Info
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona , 08035, Spain More Info
Eva Muñoz, MD
Principal Investigator
Hospital Quiron Dexeus
Barcelona , , Spain More Info
María María González Cao, MD
Contact
+34 93 546 01 35
[email protected]
María María González Cao, MD
Principal Investigator
Hospital Universitario Insular de Gran Canaria
Las Palmas De Gran Canaria , , Spain More Info
Delvys Rodríguez
Contact
+34 928 44 17 38
[email protected]
Delvys Rodríguez, MD
Principal Investigator
Hospital General Gregorio Marañón
Madrid , 29009, Spain More Info
Antonio Calles Blanco, MD
Contact
+ 34 914 26 95 16
[email protected]
Antonio Calles Blanco, MD
Principal Investigator
INCLIVA (Hospital Clinico de Valencia)
Valencia , , Spain More Info
Valentina Gambardella, MD
Contact
+34 961 97 35 31/+34 961 97 4
[email protected]
Valentina Gambardella, MD
Principal Investigator
National Taiwan University Hospital
Taipei , , Taiwan More Info
Chia-Chi Lin
Contact
[email protected]
Chia-Chi Lin
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Estimated Enrollment:

155

Study ID:

NCT04913285

Recruitment Status:

Recruiting

Sponsor:


Kinnate Biopharma

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